Are quality of life, patient preferences, and costs realistic outcomes for clinical trials?

Health-related quality of life (HRQL) is a relatively new outcome, which is being considered for incorporation into randomized, controlled clinical trials. Instruments that detect different aspects of HRQL include health profiles and utility measurements. While the results of the former are highly responsive to change over time but not easily comparable between studies, utility measurements are not as responsive to change, but as single numerical values are more comparable between studies. With the growing number of multidimensional instruments available for measurement of the quality of life, investigators must be careful to select instruments that are reliable and have been validated for incorporation into clinical trials. Similarly, investigators must choose an instrument or instruments which are best suited to detection of the primary HRQL outcomes of interest for a specific population. A relatively new method for describing the quality of life during different health states is Q-TWiST analysis. An example is provided, demonstrating how the different short-term health states of patients with small cell lung cancer can be presented and quantified. While economic evaluation has often included quality of life within the concept of the quality-adjusted life year (QALY), determination of utilities within this concept has been highly variable and the validity of the QALY as a concept has been questioned. The health years equivalent (HYE) has been proposed as a more appropriate alternative. At the health policy decision-making level, controversy persists over how much society should pay for expansive new interventions and what boundaries for allocation should be established. Much work is still needed to improve comparability of HRQL results and to incorporate these results into clinical decision making involving individual patients and health policy makers.Presented as an invited lecture at the 8th International Symposium: Supportive Care in Cancer, Toronto, Canada, 19–22 June 1996     

The work left undone. Understanding the challenge of providing holistic lung cancer nursing care in the UK

In England best practice guidance in cancer recommends that all patients have access to a specialist nurse such as the tumour specific clinical nurse specialist. The role has become pivotal providing aspects of care e.g. meeting information needs, holistic nurse led follow up including symptom control, managing care and providing psychological and social interventions including referral to others in the role of keyworker. There are approximately 295 lung cancer nurse specialists in England and recent study to model optimum caseload used an on line survey to look at workload of lung cancer specialist nurses. A survey of 100 lung cancer nurses from across the UK (RR78%) examined the perception of the work left undone against best practice guidance, caseload size, workload and other factors. 67 of 78 respondents perceived they left work such as proactive management (52) undertaking holistic needs assessments (46) providing appropriate psychological care (26) and meeting information needs (16). The majority (70) worked unpaid overtime (mean 3.8 h range 1–10 h) per week. Although proactive management is thought to result in better outcomes for lung cancer patients in terms of survival, quality of life and decisions of end of life a substantial number of the specialist nurses felt that factors such as caseload and organisational factors inhibited this.     

Cancer-related fatigue

Approximately 1.3 million people in the United States will be diagnosed with cancer in 2003 and millions of other individuals are already living with the disease. Fatigue continues to be the most prevalent and disruptive symptom of cancer and its treatment regimens. Fatigue was the most frequent and distressing cancer-related symptom occurring in women with lung cancer, two times greater than the next symptom, pain, and remains one of the most common symptoms in newly diagnosed lung cancer patients at any stage of the disease. There are many causes of cancer-related fatigue including preexisting conditions, physical and psychological symptoms caused by cancer, and the consequences of cancer treatment. High levels of fatigue decrease quality of life, physical functional status, and symptom management. This article presents an evidenced-base review of cancer-related fatigue, strategies for the management of cancer-related fatigue, and recommendations for clinical practice.     

Precision of health-related quality-of-life data compared with other clinical measures

To many clinicians, the assessment of health-related quality of life (HRQL) seems more art than science. This belief is due in part to the lack of formal training available to clinicians regarding HRQL measurement and interpretation. When HRQL is used systematically, it has been shown to improve patient-physician communication, clinical decision making, and satisfaction with care. Nevertheless, clinicians rarely use formal HRQL data in their practices. One major reason is unfamiliarity with the interpretation and potential utility of the data. This unfamiliarity causes a lack of appreciation for the reliability of data generated by formal HRQL assessment and a tendency to regard HRQL data as having insufficient precision for individual use. This article discusses HRQL in the larger context of health indicators and health outcome measurement and is targeted to the practicing clinician who has not had the opportunity to understand and use HRQL data. The concept and measurement of reliability are explained and applied to HRQL and common clinical measures simultaneously, and these results are compared with one another. By offering a juxtaposition of common medical measurements and their associated error with HRQL measurement error, we note that HRQL instruments are comparable with commonly used clinical data. We further discuss the necessary requirements for clinicians to adopt formal, routine HRQL assessment into their practices.     

Informed consent, QOL and cost benefit in the treatment of lung cancer

Ethical issues, including informed consent, quality of life and cost/benefit, are discussed. Informed consent is not only ethical discipline but also legal concept. It is important to know how and when to disclose the truth. Training and experience are critically important to acquire clinical-behavioral skill. Physicians also should know some pitfalls, including patient's right to decline information especially in terminal situation. Quality of life(QOL) is an important concept for medical practice in the treatment of lung cancer. Although several instruments have been developed for QOL measurement, poor compliance and feedback to patient care, and meaningless domains are criticized. Disease related symptom(DRS) and cost analysis should be used in future clinical trials of lung cancer.     

Health-related quality of life of ICU survivors: review of the literature.

The importance of health-related quality of life (HRQL) as a relevant outcome measure for patients requiring intensive care unit (ICU) management has only recently been recognized. A better understanding of how this expensive service affects the health and well-being of its survivors will allow nurses and other health care professionals to plan for and provide appropriate follow-up care. This paper contains a review of the theoretical basis for quality-of-life measures, discussion of some of the methodological issues, and examination of the findings from recent studies of the quality of life of ICU patients. Although not conclusive, the review identified that ICU survivors generally have poorer HRQL scores after a 6-12 month period of recovery than during their pre-admission period. This cohort also have lower HRQL than the age-adjusted general population. Despite this apparent poorer state of health, participants often claimed to be satisfied with their HRQL. Methodological weaknesses were evident in the studies reviewed, Challenges in terms of recruitment and retention of subjects, instrumentation and data collection became evident from this review. Continued research in this area is recommended and should address the weaknesses identified.     

Optimizing hospital-based home care for dying cancer patients: a population-based study

Health-related quality of life (HRQL) is difficult to define and measure. It is a generic term that includes concepts such as physical health, life satisfaction, psychological well-being and self-integrity. Realizing and appreciating the importance of HRQL is crucial for physicians if they are to be in a position to offer appropriate suggestions in assisting patients and their families in the decision-making process regarding cancer treatment and terminal care. In order to determine whether Greek physicians take into consideration HRQL when assessing different therapeutic options, we conducted a postal survey. A total of 1500 Greek physicians (internists, oncologists and anaesthesiologists) were asked to complete a questionnaire. We received replies from 1280 (85%). In summary, we found that Greek physicians: (1) have already started taking HRQL into consideration when reviewing their therapeutic options; (2) increasingly include HRQL in research studies as an outcome measure; (3) do not yet have thoroughly sufficient training in the holistic care of cancer patients and their families; (4) mostly do not have the opportunity to work in interdisciplinary therapeutic teams where they can exchange ideas and consider different aspects of alternative therapeutic methods. It is concluded that HRQL has already been introduced as an important determinant of therapeutic choices in cancer care in Greece. However, efforts need to be made to allow HRQL to enjoy its appropriate place in cancer care.     

Technology dependence and health-related quality of life: a model

AIM: This paper presents a new theoretical model to explain people's diverse responses to therapeutic health technology by characterizing the relationship between technology dependence and health-related quality of life (HRQL). INTRODUCTION: Technology dependence has been defined as reliance on a variety of devices, drugs and procedures to alleviate or remedy acute or chronic health problems. Health professionals must ensure that these technologies result in positive outcomes for those who must rely on them, while minimizing the potential for unintended consequences. Little research exists to inform health professionals about how dependency on therapeutic technology may affect patient-reported outcomes such as HRQL. Organizing frameworks to focus such research are also limited. MODEL: Generated from the synthesis of three theoretical frameworks and empirical research, the model proposes that attitudes towards technology dependence affect HRQL through a person's illness representations or commonsense beliefs about their illness. Symptom distress, illness history, age and gender also influence the technology dependence and HRQL relationship. Five concepts form the major components of the model: a) attitudes towards technology dependence, b) illness representation, c) symptom distress, d) HRQL and e) illness history. CONCLUSION: The model is proposed as a guide for clinical nursing research into the impact of a wide variety of therapeutic health care interventions on HRQL. Empirical validation of the model is needed to test its generality.     

A Randomized Trial of Weekly Symptom Telemonitoring in Advanced Lung Cancer

ContextLung cancer patients experience multiple, simultaneous symptoms related to their disease and treatment that impair functioning and health-related quality of life (HRQL). Computer technology can reduce barriers to nonsystematic, infrequent symptom assessment and potentially contribute to improved patient care.ObjectivesTo evaluate the efficacy of technology-based symptom monitoring and reporting in reducing symptom burden in patients with advanced lung cancer.MethodsThis was a prospective, multisite, randomized controlled trial. Two hundred fifty-three patients were enrolled at three sites and randomized to monitoring and reporting (MR) or monitoring alone (MA). Patients completed questionnaires at baseline, 3, 6, 9, and 12 weeks and symptom surveys via interactive voice response weekly for 12 weeks. MR patients' clinically significant symptom scores generated an e-mail alert to the site nurse for management. The primary endpoint was overall symptom burden; secondary endpoints included HRQL, treatment satisfaction, symptom management barriers, and self-efficacy.ResultsThis randomized controlled trial failed to demonstrate efficacy of symptom monitoring and reporting in reducing symptom burden compared with monitoring alone in lung cancer. HRQL declined over 12 weeks in both groups (P < 0.006 to P < 0.025); at week 12, treatment satisfaction was higher in MA than MR patients (P < 0.012, P < 0.027). Adherence to weekly calls was good (82%) and patient satisfaction was high.ConclusionFeasibility of using a technology-based system for systematic symptom monitoring in advanced lung cancer patients was demonstrated. Future research should focus on identifying patients most likely to benefit and other patient, provider, and health system factors likely to contribute to the system's success.     

Symptoms in adults with lung cancer. A systematic research review

Health care providers play a key role in providing adequate symptom management and promoting quality of life during chronic illness. Several studies have noted that adults with lung cancer experience more symptom distress than patients with other types of cancer. Therefore, symptom management in this group of patients is particularly important. An understanding of the research conducted in this area is important for further knowledge development and for potentially improving symptom management. This paper presents a systematic review of empirical studies examining symptoms in adults with lung cancer. The results of this systematic review revealed that although major strides have been made in understanding symptoms associated with lung cancer, further progress is needed to decrease the morbidity associated with uncontrolled symptoms. Theoretical, conceptual, and/or methodological issues identified through this review must be addressed in future research. In particular, the researcher should provide information about the theoretical or empirical framework guiding the study, give an explicit definition about the dimensions of the symptom experience being studied, report refusal rates and attrition, and use instruments that are reliable and valid.     

Health limitations and quality of life associated with cancer and other chronic diseases by phase of care

OBJECTIVE: To estimate health limitations and health-related quality of life (HRQL) associated with cancer and other chronic conditions in a nationally representative sample within a phase-of-care framework. STUDY DESIGN AND SETTING: We used a nested case-control design to assess health limitations and HRQL in individuals reporting a breast, colorectal, prostate, or lung cancer diagnosis, or a diagnosis of arthritis, diabetes, heart disease, or hypertension compared with similar controls without these conditions. All subjects were selected from the 1986-1994 National Health Interview Surveys linked to mortality files in 1995, and classified into the initial, continuing, or last year of life phase of care. Health limitations and HRQL were compared for cases and controls for each condition with 2-sided statistical tests. RESULTS: Across all conditions, individuals in the last year of life phase of care reported greater health limitations and lower HRQL, as measured by the Health Activities and Limitations Index (HALex), than did individuals in the initial and continuing phases of care. Compared with their matched controls, individuals with cancer or other chronic conditions were more likely to report health limitations and lower mean HALex values in the initial, continuing, and last year of life phases of care (P < 0.05). CONCLUSIONS: We observed greater health limitations and lower HRQL associated with cancer and other chronic diseases compared with similar individuals without these conditions. The phase-of-care framework used in this study seems to be applicable to the assessment of HRQL for cancer and other chronic diseases.     

Impact of symptom burden in post-surgical non-small cell lung cancer survivors

Purpose

Pain, fatigue, dyspnea, and distress are commonly reported cancer-related symptoms, but few studies have examined the effects of multiple concurrent symptoms in longer-term cancer survivors. We examined the impact of varying degrees of symptom burden on health-related quality of life (HRQOL) and performance status in surgically treated non-small cell lung cancer (NSCLC) survivors.

Methods

A sample of 183 NSCLC survivors 1–6 years post-surgical treatment completed questionnaires assessing five specific symptoms (pain, fatigue, dyspnea, depression, and anxiety), HRQOL, and performance status. The number of concurrent clinically significant symptoms was calculated as an indicator of symptom burden.

Results

Most survivors (79.8 %) had some degree of symptom burden, with 30.6 % reporting one clinically significant symptom, 27.9 % reporting two symptoms, and 21.3 % reporting three or more symptoms. Physical HRQOL significantly decreased as the degree of symptom burden increased, but mental HRQOL was only significantly decreased in those with three or more symptoms. Receiver-operating characteristic (ROC) curves showed that having multiple concurrent symptoms (two or more) was most likely associated with limitations in functioning (area under a ROC curve?=?0.75, sensitivity?=?0.81, specificity?=?0.54).

Conclusions

Two or more clinically significant symptoms are identified as the “tipping point” for showing adverse effects on HRQOL and functioning. This highlights the need for incorporating multiple-symptom assessment into routine clinical practice. Comprehensive symptom management remains an important target of intervention for improved post-treatment HRQOL and functioning among lung cancer survivors.     

Health-related quality of life in patients treated for hypertension: a review of the literature from 1990 to 2000

BACKGROUND: The goals of antihypertensive therapy are to achieve and maintain blood pressure control by the least intrusive means possible to prevent future cardiovascular and renal events. To achieve these goals, pharmacologic agents must be chosen so as to minimize drug-related adverse events, increase patient adherence to treatment regimens, and minimize the negative impact on health-related quality of life (HRQL). Although the effects of antihypertensive therapy on HRQL have been extensively investigated, there is little synthesis of the research findings. OBJECTIVE: This review was undertaken to provide a synthesis of the available data on the impact of antihypertensive therapy on HRQL and to provide recommendations for future research. METHODS: A MEDLINE literature search was conducted to identify English-language articles published from 1990 to 2000 that included random assignment to antihypertensive treatment and HRQL as an outcome. In addition, reference lists of published reviews and other trials were reviewed to identify other studies of HRQL and antihypertensive therapy. RESULTS: A total of 48 articles were included in the review. Results among studies were frequently inconsistent, which is likely due to the wide variety of dimensions studied and instruments used as well as a number of methodological weaknesses, including small sample sizes, short-term assessments, and failure to account for missing data. CONCLUSION: A standardized approach to the assessment of HRQL in hypertensive patients is needed so that research in this area can be of value to clinical practice and to hypertensive patients and their families.     

Enhancing postoperative recovery of cardiac surgery patients: a randomized clinical trial of an advanced practice nursing intervention

The purpose of this trial was to determine the effectiveness of advanced practice nursing support on cardiac surgery patients' during the first 5 weeks following hospital discharge. Patients ( N = 200) were randomly allocated to two groups: (a) an intervention group who received telephone calls from an advanced practice nurse (APN) familiar with their clinical condition and care needs, twice during the first week following discharge then weekly thereafter for 4 weeks, and (b) a usual care group. Measures of health-related quality of life (HRQL), symptom distress, satisfaction with recovery care, and unexpected health care contacts were obtained at 5 weeks following discharge. There were no significant group differences in HRQL, unexpected contacts with the health care system, or symptom distress. The provision of APN support via telephone followup after cardiac surgery is feasible. However, further randomized trials of single and multicomponent APN interventions are needed to prove effectiveness.     

Idiopathic Pulmonary Fibrosis: A Review of Disease,Pharmacological, and Nonpharmacological Strategies With a Focus on Symptoms,Function, and Health-Related Quality of Life

Despite several advances in treatment, idiopathic pulmonary fibrosis (IPF) remains a progressive, symptomatic, and terminal disease in patients not suitable for lung transplantation. With disease progression, IPF often leads to a constellation of symptoms, including dyspnea, cough, anxiety, and depression. Palliative care is appropriate to support these patients. However, traditional curriculum in palliative care has often focused on supporting patients with malignant disease, and clinicians are not universally trained to manage patients with progressive nonmalignant diseases such as IPF. Current antifibrotic therapies aim to slow disease progression but are not able to reduce symptoms or improve daily function and health-related quality of life (HRQL). Palliative care in this patient group requires an understanding of the clinical characteristics of IPF, comorbidities, common medications used, and nonpharmacological strategies that can be undertaken to improve daily function and HRQL. This review focuses on IPF management strategies and their effects on symptoms, exercise tolerance, HRQL, and survival. Pharmacological interactions and considerations related to commonly used palliative care medications are also reviewed. This review highlights the needs of patients with IPF and caregivers, psychosocial function, patient-reported assessment tools, and topics related to advance care planning.     

Using focus groups to inform the Neuro-QOL measurement tool: exploring patient-centered, health-related quality of life concepts across neurological conditions.

Measurement of health-related quality of life (HRQL) is of particular importance in neurology clinical trials, where differences in clinical measurements or laboratory data may not translate into significant benefit to the patients. A fundamental consideration in the development and use of an HRQL instrument is whether the instrument's conceptual framework accurately reflects the HRQL experience of the population of interest. This study details the findings from formative research that focused on the identification of content area for an HRQL measurement system in neurology. Specifically, 11 focus groups were conducted with caregivers and patients diagnosed with 7 neurological conditions that represented a range of symptomatology and ages. Through an analytic process using techniques derived from grounded theory, several themes emerged that describe the complexity of HRQL issues and the impact of neurological disorders on multiple areas of life functioning and experience. Findings suggest that although HRQL is comparable across neurological disorders, the contribution of specific domains to overall HRQL may differ among disorders.     

需求理论下肺癌化疗患者对消化道症状群认知态度及饮食营养管理需求的质性研究

目的：探究需求理论下肺癌化疗患者对消化道症状群的真实认知态度及饮食营养管理需求的质性研究。方法：采用目的抽样方法,选取2021年10～11月南昌市某三甲医院呼吸科收治的16例肺癌化疗患者为研究对象,进行半结构式深入访谈,并运用现象学分析法进行资料分析。结果：通过访谈归纳出三个主题,分别是肺癌化疗患者普遍出现消化道症状但缺乏多渠道的正向行为;肺癌化疗患者对消化道症状群信息管理平台需求较高;肺癌化疗患者出现消化道不适症状时,对营养、饮食的信息需求较大。结论：医护人员应准确评估患者对消化道症状群的认知情况及饮食营养管理需求,实现对消化道症状群的科学管理,提高患者营养水平和生活质量。     

Health-related quality of life in pediatric oncology: current status and future challenges.

This article presents information regarding the current status of health-related quality of life (HRQL) assessment in pediatric oncology, including the substantial advances in our knowledge that have occurred during the past 10 years. Additionally, issues that continue to challenge researchers who are attempting to measure health-related quality of life in children from point of diagnosis to cure or to death are identified. It is posited that researchers must conduct investigations of the impact of health-related quality-of-life data on clinical care and outcomes for the field to continue to advance, and for these data to be valued by patients, families, and health care providers.     

Using clinical outcomes to identify expert physical therapists

BACKGROUND AND PURPOSE: Previous studies of expert physical therapists have sampled therapists based on years of clinical experience or reputation, not on their patients' clinical outcomes. The purposes of this study were to identify expert physical therapists by using patient self-reported outcomes and to describe the characteristics of clinicians whose patients with lumbar spine syndromes reported higher health-related quality of life (HRQL) following rehabilitation. METHODS: Retrospective data were analyzed on 24276 patients (mean age=47.8 years, SD=16, range=14-97) with lumbar spine syndromes treated by 930 physical therapists participating in the Focus On Therapeutic Outcomes database in 1999-2000. Physical therapists and staff answered questions concerning years of experience and practice setting when starting their participation in the outcomes system. Patient self-report HRQL data were collected at intake and discharge from outpatient rehabilitation. Discharge HRQL data were risk adjusted using patient characteristics. Data were aggregated by physical therapist. Risk-adjusted discharge HRQL scores were used to classify physical therapists whose patients reported mean HRQL improvement above the 90th percentile as experts and physical therapists whose patients reported mean HRQL improvement between the 45th and 55th percentiles as average. RESULTS: Therapists classified as expert had fewer patients in the database than did therapists classified as average (mean SD) (19 +/-17 versus 29 +/-22). Mean treatment duration was different between groups (32 +/- 11 days for the expert group versus 31+/-8 days for the average group). DISCUSSION AND CONCLUSION: The results challenge assumptions that extensive clinical experience is necessary to achieve superior patient outcomes, and they provide information about the relationship between therapist characteristics and patient outcomes.